Senior Director, Regulatory Affairs CMC

Job not on LinkedIn

🔥 14 hours ago

🏖️ New Jersey, Maryland, +3 more states – Remote

🏖️ New Jersey – Remote 🦀 Maryland – Remote 🍂 Massachusetts – Remote 🔔 Pennsylvania – Remote ⚔️ Virginia – Remote

💵 $250k - $272k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

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Miltenyi Biotec

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Miltenyi Biotec is a global biotechnology company that develops and manufactures instruments, reagents, and software for cell separation, flow cytometry, single-cell analysis, and cell and gene therapy research and manufacturing. Its products and services support academic research, translational studies, and clinical manufacturing workflows, enabling isolation, analysis and manipulation of cells for immunology, neuroscience, cancer research and regenerative medicine.

📋 Description

• Lead the team of global CMC Regulatory Affairs managers • Serve as the global regulatory expert for Chemistry, Manufacturing & Controls activities supporting the Cell & Gene Therapy portfolio • Provide strategic regulatory leadership across development, registration and lifecycle management • Coach, mentor and lead global CMC Regulatory Affairs managers • Lead global CMC regulatory strategies for Cell & Gene Therapy products throughout development and commercialization • Oversee, develop strategy for, review and approve CMC sections for regulatory submissions, including INDs, CTAs, BLAs, MAAs, amendments and post-approval variations • Provide strategic guidance on regulatory requirements related to manufacturing processes, analytical methods, specifications, comparability studies, process validation and control strategies • Assess regulatory impact of manufacturing changes and define appropriate regulatory pathways worldwide • Support interactions with global health authorities including FDA, EMA, MHRA and other agencies • Collaborate with Process Development, Manufacturing, Quality, Supply Chain and Clinical Development functions • Monitor regulatory developments and industry trends relevant to advanced therapies and translate them into regulatory strategies • Drive regulatory risk assessments and mitigation plans across the product lifecycle • Perform duties in an office environment and meet specified physical demands

🎯 Requirements

• Master's degree or PhD in Pharmacy, Biotechnology, Biology, Chemistry or related scientific discipline • +12 years demonstrated hands-on expertise in Chemistry, Manufacturing & Controls (CMC) Regulatory Affairs for Cell & Gene Therapy (CGT) products is mandatory • Extensive experience in Regulatory Affairs within biotechnology and/or pharmaceutical environments • Proven experience supporting global regulatory submissions and interactions with health authorities, particularly in Europe and the US • Deep understanding of biologics, ATMPs, Cell & Gene Therapy products and global regulatory frameworks • Excellent communication, leadership and project management skills • Fluent English written and verbal communication skills • Substantial regulatory affairs strategy and submissions experience in one or more of: cell therapies, gene therapies, viral vectors, Advanced Therapy Medicinal Products (ATMPs), biological product development and manufacturing • Ability to handle more than one task at a time • Ability to perform the stated physical duties, including occasionally lifting or moving up to 25 pounds

🏖️ Benefits

• Health insurance • Vision insurance • Dental insurance • 401(k) plan • Additional compensation such as bonuses or commissions may be available for certain positions • Reasonable accommodations for candidates and employees with disabilities